Evaluating the Effectiveness of a Family Heart Health Educational Program (The FIT-Heart Study) (FIT-Heart)

May 14, 2013 updated by: Lori Mosca, Columbia University

Effectiveness of a Family Heart Health Intervention Trial (FIT Heart I)

The primary objective of the FIT Heart Study was to test the effectiveness of a hospital-based standardized screening and educational intervention targeted to family members of patients hospitalized with CVD, to increase adherence to CVD prevention guidelines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

FIT Heart was a randomized controlled trial that tested a novel systems approach to increase adherence to national prevention guidelines among family members of patients hospitalized with CVD. Participants were blood relatives or cohabitants of patients hospitalized with atherosclerotic cardiovascular disease, aged 20-79 years, did not have established cardiovascular disease or diabetes, and spoke English or Spanish. Participants randomized to a special intervention group received behavioral counseling and education on diet and physical activity; personalized risk factor screening and immediate feedback; and reinforcement and follow-up throughout the year. The control group received a brief CVD prevention message in the form of a handout. All participants received standardized assessments of diet, lifestyle, and CVD risk factors at baseline and 1 year (94% follow-up). The main findings have been published showing the mean percent change in LDL-cholesterol level from baseline to 1-year improved in both groups and was not significantly different in the special intervention vs. control group (-1% vs. -2%; p=.64).

Study Type

Interventional

Enrollment (Actual)

501

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Life expectancy of at least 5 years after study entry
  • Willing to return at Year 1 for a repeat study evaluation
  • Family member was hospitalized with acute atherosclerotic cardiovascular disease, including catheter-based procedures and coronary artery bypass grafting
  • Speaks either English or Spanish

Exclusion Criteria:

  • Established cardiovascular disease, diabetes, active liver disease, or long-term kidney disease
  • Life expectancy less than 5 years from study entry
  • Prescription of a special diet that is not compatible with the TLC diet
  • Participation in a clinical drug study in the 3 months before study entry
  • Pregnant or planning to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants took part in the Family Passport to Heart Health Program.
Behavioral: Family Passport to Heart Health Program
Participants in this group received personalized heart disease risk factor screening at the baseline study visit. They were taught lifestyle approaches to risk reduction based upon national heart disease prevention guidelines, including the Adult Treatment Panel (ATP) III recommendations for improving blood cholesterol levels with a TLC diet. Participants had regular contact with study staff and will receive individualized feedback throughout the study.
Active Comparator: 2
Participants took part in a control group.
Behavioral: General Educational Materials
Participants in the control group received an educational brochure about heart health at the baseline study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean percent reduction in low-density lipoprotein (LDL) cholesterol levels in the special intervention group versus the control group
Time Frame: Measured at Year 1
Measured at Year 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean percent change in high density lipoprotein (HDL) cholesterol levels in the special intervention group versus the control group
Time Frame: Measured at Year 1
Measured at Year 1
Attainment of the Therapeutic Lifestyle Change (TLC) diet
Time Frame: Measured at Year 1
Measured at Year 1
Change in lipoproteins, high sensitivity C-reactive protein (hsCRP), blood pressure, body mass index, waist circumference, Framingham risk, and diet score in the special intervention group versus the control group
Time Frame: Measured at Year 1
Measured at Year 1
Cost effectiveness of the personalized educational program to reduce LDL cholesterol levels and cost per life saved
Time Frame: Measured at Year 1
Measured at Year 1
Impact of hsCRP beyond traditional risk factors on attainment of prevention goals
Time Frame: Measured at Year 1
Measured at Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Lori Mosca, MD, MPH, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAA5856
  • R01HL075101 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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